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Tag: biotechnology


Cell and Gene Therapy, FDA, Industry, Regulations

FDA decision on Bristol Myers cell therapy could come down to the wire

September 22, 2020

Via: Biopharma Dive

Celgene gained rights to ide-cel through a 2018 deal with Bluebird bio, the experimental therapy’s original developer. When Bristol-Myers made its bid to buy Celgene, the two sides couldn’t agree to the long-term value of ide-cel, the now-approved multiple sclerosis […]


Cell and Gene Therapy, FDA, Industry, Regulations

Emmecell exits stealth mode as FDA greenlights clinical trials of cornea cell therapy

September 22, 2020

Via: FierceBiotech

Corneal transplantation can help people who are losing their sight thanks to degenerating corneas, but it’s “probably the most aggressive surgery” that already highly trained corneal specialists do, said Roger Goldberg, M.D., a retinal surgeon. “It’s not a decision they […]


Clinical Trials, Research and Development

Gene Drive Control Worry Eased by Genetic Neutralizing Elements

September 21, 2020

Via: Genetic Engineering and Biotechnology News

Reducing the burden of mosquito-borne infectious diseases is the goal of many researchers. Strategies such as the distribution of mosquito nets and repellents have had some success, while many are innovating new ways to suppress the mosquito population in an […]


Biotech, Industry

Genetic Engineering Across the Tree of Life

September 21, 2020

Via: Genetic Engineering and Biotechnology News

Industrial bioengineering is now using genetically modified microbes to produce a wide array of products at industrial scale, including everything from biofuels to nutraceuticals such as resveratrol. But despite the diversity of output, the primary organisms producing them are modified […]


Clinical Trials, Research and Development

Scientists Solve High-Resolution Structure of Psychedelic Drugs Bound to Serotonin Receptors

September 18, 2020

Via: Genetic Engineering and Biotechnology News

Psychedelic drugs such as LSD, psilocybin, and mescaline cause severe and often long-lasting hallucinations, but they also show great potential in treating a number of serious psychiatric conditions, such as major depressive disorder. The results of new research headed by […]


Clinical Trials, Research and Development

SARS-CoV-2 Spike Protein Forms Ten Distinct Structures with ACE2

September 18, 2020

Via: Genetic Engineering and Biotechnology News

A SARS-CoV-2 infection begins when the virus’s spike proteins bind to ACE2 cell surface receptors, enabling the virus to infect human cells. This key event of the receptor binding is followed by fusion of the virus and cell membranes to […]


Industry, Vaccines

Moderna says it will begin developing a vaccine for seasonal flu

September 17, 2020

Via: CNBC

Biotech firm Moderna said Thursday it will begin developing a vaccine for the influenza season. “We are announcing that we are increasing our investment in vaccines and we will develop a seasonal flu vaccine given the unmet need for highly […]


Cell and Gene Therapy, Industry, News

Culprit Behind Immunotherapy Resistance in Some Lymphomas Revealed

September 17, 2020

Via: Genetic Engineering and Biotechnology News

Cancer treatments can be unsuccessful due to malignant cells surviving radiation, chemotherapy, or by evading apoptosis. Now researchers from the University of Tsukuba in Japan, demonstrate how the protein Livin—an apoptosis inhibitor—allows some lymphomas to resist therapy, and how targeting […]


FDA, Regulations

FDA Clears IND Application for Vaxart Oral COVID-19 Vaccine

September 16, 2020

Via: Contract Pharma

The U.S. Food and Drug Administration (FDA) has completed its review of Vaxart Inc.’s Investigational New Drug (IND) application for its Phase 1 clinical trial evaluating its oral COVID-19 vaccine candidate. “Our goal is to deliver the best, most elegant […]


FDA, News, Regulations

Trump health officials prepare to distribute coronavirus vaccine within 24 hours of OK from FDA

September 16, 2020

Via: CNBC

The U.S. government plans to transport a coronavirus vaccine to distribution sites across the U.S. within 24 hours after the Food and Drug Administration grants an emergency authorization or approval, senior administration officials said Wednesday. The government will use medical […]


Industry, Vaccines

Automation a Key Focus for Moderna’s COVID-19 Vaccine Contractor

September 15, 2020

Via: Genetic Engineering and Biotechnology News

Moderna hired Lonza to make its COVID-19 vaccine in May. Initially, the CDMO will manufacture the vaccine active ingredient—an mRNA molecule in lipid nanoparticles—at plants in the United States and Switzerland. However, the firms plan to establish additional production suites […]


Manufacturing, Research and Development

Sensors Take on Undersampling in Biomanfacturing

September 15, 2020

Via: Genetic Engineering and Biotechnology News

When asked about the biggest challenge in today’s bioprocessing, Sandy Williams, PhD, a biomedical engineering expert at Scientific Bioprocessing (SBI) in Pittsburgh who focuses on regenerative medicine, says, “The biggest concern we have heard from the industry is that bioprocessing […]